HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHIC ANALYSIS OF LACTIC-ACID AND LACTIC-ACID LACTATE IN AMRINONE LACTATE FORMULATIONS

A high performance liquid chromatographic method for the quantitation of lactic acid in Amrinone Lactate formulations is described. Samples were separated using a Dionex HPICE-AS1 ion chromatography exclusion c olumn and a mobile phase of 1 mM sodium octanesulfonate. A conductivit y detector equipped with an anion micromembrane suppressor was used an d regenerated with 5 mM tetrabutylammonium hydroxide. The method demon strated a recovery of 100.3% with a linear correlation coefficient of the standards of 0.9999. The selectivity of the method was demonstrate d by showing the absence of chromatographic interference by other form ulation components. The method also separates lactic acid lactate from lactic acid. Studies conducted on samples of Amrinone Lactate Injecti on and placebo demonstrated a temperature related equilibrium between lactic acid and lactic acid lactate.